Psychosocial Outcomes with the Omnipod® 5 Automated Insulin Delivery System in Children and Adolescents with Type 1 Diabetes and Their Caregivers

Author:

Hood Korey K.1,Polonsky William H.23,MacLeish Sarah A.4,Levy Carol J.5,Forlenza Gregory P.6ORCID,Criego Amy B.7,Buckingham Bruce A.8,Bode Bruce W.9,Hansen David W.10,Sherr Jennifer L.11,Brown Sue A.12,DeSalvo Daniel J.13,Mehta Sanjeev N.14,Laffel Lori M.14,Bhargava Anuj15,Huyett Lauren M.16,Vienneau Todd E.16,Ly Trang T.16ORCID

Affiliation:

1. Department of Pediatrics, Psychiatry & Behavioral Sciences, Stanford Diabetes Research Center, Stanford University School of Medicine, Stanford University, Stanford, CA, USA

2. University of California San Diego, San Diego, CA, USA

3. Behavioral Diabetes Institute, San Diego, CA, USA

4. University Hospitals Cleveland Medical Center, Rainbow Babies and Children’s Hospital, Cleveland, OH, USA

5. Icahn School of Medicine at Mount Sinai, New York, NY, USA

6. Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO, USA

7. International Diabetes Center, Health Partners Institute, Minneapolis, MN, USA

8. Department of Pediatrics, Division of Pediatric Endocrinology, Stanford University, Stanford, CA, USA

9. Atlanta Diabetes Associates, Atlanta, GA, USA

10. Department of Pediatrics, SUNY Upstate Medical University, Syracuse, NY, USA

11. Department of Pediatrics, Yale School of Medicine, New Haven, CT, USA

12. Division of Endocrinology, Center for Diabetes Technology, University of Virginia, Charlottesville, VA, USA

13. Department of Pediatrics, Baylor College of Medicine, Houston, TX, USA

14. Joslin Diabetes Center, Harvard Medical School, Boston, MA, USA

15. Department of Research, Iowa Diabetes Research, West Des Moines, IA, USA

16. Insulet Corporation, Acton, MA, USA

Abstract

Objective. While automated insulin delivery (AID) systems aim to improve glycemic outcomes, the opportunity to improve psychosocial outcomes is also of critical importance for children and adolescents with type 1 diabetes and their caregivers. We evaluated psychosocial outcomes in these groups during a clinical trial of a tubeless AID system, the Omnipod® 5 Automated Insulin Delivery System. Methods. This single-arm, multicenter, prospective study enrolled 83 children (6.0–11.9 years) and 42 adolescents (12.0–17.9 years) with type 1 diabetes to use a tubeless AID system for 3 months. Participants and their caregivers completed age- and role-appropriate validated questionnaires to assess changes in psychosocial outcomes—diabetes distress (PAID), hypoglycemia confidence (HCS), well-being (WHO-5), sleep quality (PSQI), insulin delivery satisfaction (IDSS), and system usability (SUS)—before and after 3 months of AID system use. Associations between participant characteristics and glycemic outcomes with psychosocial measures were evaluated using linear regression analyses. Results. Improvements were found for children, adolescents, and/or their caregivers for diabetes-related distress, insulin delivery satisfaction, and system usability (all P < 0.05 ). Caregivers of children saw additional benefits of improved general well-being, confidence in managing hypoglycemia, and sleep quality (all P < 0.05 ). Regression analyses showed that improvements in psychosocial outcomes were generally independent of baseline characteristics and changes in glycemic outcomes. Conclusions. The tubeless AID system was associated with significant improvements in a number of psychosocial outcomes for children, adolescents, and their caregivers. Trial registration: This trial is registered with NCT04196140.

Funder

Insulet Corporation

Publisher

Hindawi Limited

Subject

Endocrinology, Diabetes and Metabolism,Pediatrics, Perinatology and Child Health,Internal Medicine

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